[Federal Register Volume 72, Number 240 (Friday, December 14, 2007)]
[Proposed Rules]
[Pages 71083-71086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24291]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 72, No. 240 / Friday, December 14, 2007 /
Proposed Rules
[[Page 71083]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 51
[Docket No. PRM-51-11]
Sally Shaw; Denial of Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Denial of petition for rulemaking.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition
for rulemaking (PRM) submitted by Sally Shaw on June 23, 2006. The
petition, docketed as PRM-51-11, requests that the NRC prepare a
rulemaking to reconcile NUREG-1437, ``Generic Environmental Impact
Statement for License Renewal of Nuclear Plants'' (May 1996) (GEIS),
for nuclear power plant operating license renewal applications with the
National Academy of Sciences' (NAS), ``Health Risks From Exposure to
Low Levels of Ionizing Radiation: Biological Effects of Ionizing
Radiation (BEIR) VII, Phase 2,'' Seventh Ed., 2005 report. The
petitioner believes that this action is necessary because the BEIR VII
report represents new and significant information on radiation
standards and risk factors that must be reflected in NRC's GEIS.
Although the NRC recognizes that the petition highlighted that BEIR VII
contains a more refined risk assessment based on additional medical
data and a better dosimetry system, the NRC is denying PRM-51-11
because it does not provide significant information or arguments that
were not previously considered by the Commission.
ADDRESSES: Publicly available documents related to these petitions and
the NRC's letter of denial to the petitioner may be viewed
electronically on public computers in the NRC's PublicDocument Room
(PDR), 01 F21, One White Flint North, 11555 Rockville Pike, Rockville,
Maryland. The PDR reproduction contractor will copy documents for a
fee. Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, the public can gain entry into the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of NRC's public documents. If you do not have access to ADAMS or
if there are problems in accessing the documents located in ADAMS,
contact the PDR reference staff at (800) 387-4209, (301) 415-4737 or by
e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: David T. Diec, telephone (301) 415-
2834, e-mail [email protected], or Andrew Luu, telephone (301) 415-1078, e-
mail [email protected], Office of Nuclear Reactor Regulation, Nuclear
Regulatory Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
The Petition
On November 20, 2006 (71 FR 67072), the NRC published a notice of
receipt of a petition for rulemaking filed by Sally Shaw (the
petitioner). The petitioner requested that the NRC reconcile the GEIS
with the NAS BEIR VII report, which was released in 2005. The GEIS
incorporates data from BEIR V, an earlier NAS report that was released
in 1990. The NRC regulation, Part 10 of the Code of Federal Regulations
Section 51.95(c), requires that the NRC prepare a supplemental
environmental impact statement (SEIS) to the GEIS. The findings of the
GEIS are set forth in Table B-1 of Appendix B to subpart A of 10 CFR
part 51 (Table B-1). A copy of the petition can be found in ADAMS under
accession number ML061770056.
Specifically, the petitioner requests that the NRC consider the NAS
BEIR VII report as new and significant information and update the
radiological impacts and conclusions set forth in the GEIS, including
early fatalities, latent fatalities, and any injury projections based
on this information. The petitioner asserts that BEIR VII represents
the ``current science,'' and states that BEIR VII, unlike BEIR V,
``estimates risks for cancer incidence rates as well as mortality and
also provides detailed risk figures according to age of exposure for
males and females, by cancer type.'' According to the petitioner, BEIR
VII shows that the cancer mortality risks for women and children are
much higher than for men. Further, the petitioner asserts that the
GEIS's radiological impact analysis is calculated based on an
``arbitrary and false'' threshold dose model, implying that a dose
received below the threshold would not be of ``regulatory concern.'' In
this regard, the petitioner refers to BEIR VII, which concludes that
there is no evidence of a ``threshold dose phenomenon.''
The petitioner also asserts that the GEIS reports radiation risks
to nuclear workers of one rem per year based on BEIR V. The petitioner
requests that these radiation risks be recalculated using BEIR VII and
the latest science in medical journals, which include exposure to
internal radiation sources (alpha and beta emitters, via inhalation or
ingestion). Finally, the petitioner asserts that the radiological
impact analysis contained in the GEIS assumes that non-stochastic
effects will not occur if the dose equivalent from internal and
external sources combined is less than 50 rem per year and, as such,
must be recalculated in light of BEIR VII.
NRC Evaluation
The petitioner's request is that the NRC reconcile the GEIS with
the NAS BEIR VII, 2005 report. The NRC's regulations for implementing
its responsibilities under the National Environmental Policy Act (NEPA)
are contained in 10 CFR part 51, ``Environmental Protection Regulations
for Domestic Licensing and Related Regulatory Functions.'' The renewal
of a nuclear power plant operating license is identified as a major
Federal action significantly affecting the quality of the human
environment, and thus an SEIS (in conjunction with the GEIS) is
required before the NRC determines whether to approve or disapprove the
license renewal application. The NRC's requirements for renewal of
operating licenses for nuclear power plants are contained in 10 CFR
part 54. The GEIS assesses environmental impacts that could be
associated with nuclear power plant license renewal and establishes
generic findings for each type of environmental impact covering as many
plants as possible. The GEIS reflects the NRC's findings regarding
those environmental impacts associated with
[[Page 71084]]
license renewal that are well understood.
GEIS
The GEIS assesses the various environmental impacts associated with
license renewal in terms of significance and assigns one of three
significance levels to a given impact--small, moderate, or large. A
small impact means that the environmental effects are not detectable or
are so minor that they will neither destabilize nor noticeably alter
any important attribute of the resource. For the purpose of assessing
radiological impacts, the NRC has concluded that those impacts that do
not exceed permissible levels in the NRC's regulations are considered
small. A moderate impact means that the environmental effects are
sufficient to alter noticeably but not to destabilize important
attributes of the resource. A large impact means that the environmental
effects are clearly noticeable and are sufficient to destabilize
important attributes of the resource.
In addition to determining the significance of environmental
impacts associated with license renewal, the NRC determines if its
analysis can be applied to all plants and whether additional mitigation
measures would be warranted. The GEIS sets forth two categories:
Category 1 and Category 2. Category 1 means that the GEIS analysis has
shown that the environmental impacts associated with the issue have
been determined to apply either to all plants or, for some
environmental issues, to plants having a specific type of cooling
system or other specified plant or site characteristics; a single
significance level (i.e., small, moderate, or large) has been assigned
to the impacts; mitigation of adverse impacts associated with the issue
has been considered in the analysis; and it has been determined that
additional plant-specific mitigation measures are not likely to be
sufficiently beneficial to warrant implementation. Category 2 means
that the GEIS analysis does not meet the criteria of Category 1, and
thus, on that particular environmental issue, additional plant-specific
review is required. The GEIS findings are set forth in Table B-1 of
Appendix B to subpart A of 10 CFR part 51.
For each license renewal application, the NRC will prepare a draft
SEIS to analyze those plant-specific (Category 2) issues. The SEIS is
not required to cover any Category 1 issues. The draft SEIS is made
available for public comment. After consideration of any public
comments, the NRC will prepare and issue a final SEIS under 10 CFR
51.91 and 51.93. The final SEIS and the GEIS serve as the requisite
NEPA analysis for any given license renewal application.
The GEIS analysis, as shown in Table B-1, concluded that both
public and occupational radiation exposures during any plant
refurbishment or plant operation through the license renewal term are
of a small significance level and meet all Category 1 criteria. This
conclusion is based on a given licensee's adherence to, and if
necessary, NRC enforcement of, the dose limits as required in 10 CFR
part 20, ``Standards for Protection Against Radiation'' and in Appendix
I to 10 CFR part 50, ``Numerical Guides for Design Objectives and
Limiting Conditions for Operation to Meet the Criterion `As Low As Is
Reasonably Achievable' (ALARA) for Radioactive Material in Light-Water-
Cooled Nuclear Power Reactor Effluents.'' Regulations at 10 CFR part 20
require that a licensee limit the annual dose to a member of the public
to no more than 0.1 rem (1mSv) total effective dose equivalent (TEDE).
In addition, 40 CFR part 190, ``Environmental Radiation Protection
Standards For Nuclear Power Operations,'' further restricts the
allowable annual dose to a member of the public to a lower value of
0.025 rem (0.25 mSv) and to maintain doses to members of the public
that are ALARA. Finally, 10 CFR 50.34a requires a nuclear power plant
to maintain control over radioactive gaseous and liquid effluents
produced during normal operations to dose levels contained in Appendix
I to 10 CFR Part 50, which are in the range of 0.003 rem (0.03 mSv) to
0.005 rem (0.05 mSv).
BEIR Reports
The risk estimates of human health effects from radiation were
first evaluated by scientific committees starting in the 1950s. Since
1972, the National Academy of Sciences has published a series of
reports on the biological effects of ionizing radiation (the BEIR
reports), including the BEIR V report in 1990 and the BEIR VII report
in 2005. The BEIR V and BEIR VII reports concentrated primarily on
providing a comprehensive review of all biological and biophysical data
regarding the health effects attributable to exposures to low doses of
ionizing radiation, ranging between 0 to 10 rem (0-100 mSv). Although
the BEIR VII committee examined several sources of epidemiological data
(i.e., medical and occupational exposures), the single most important
source of epidemiological data is the cohort of 120,000 Japanese atomic
bomb survivors from the cities of Hiroshima and Nagasaki.
Three major changes have occurred after the BEIR V report was
published. First, an additional 12 years of follow-up medical data are
available. Second, cancer incidence data for the cohort are available
(for BEIR V, only mortality data were available). The impact of these
two developments has reduced the uncertainty in the assessment of
cancer risk among the atomic bomb survivors. Third, the dosimetry
system used to assign radiation exposure to the atomic bomb survivors
was replaced with an improved dosimetry system. These changes have
improved our understanding of the health risks associated with
radiation exposure. The overall risk estimates of the BEIR V and BEIR
VII reports, however, remain statistically insignificant. In this
regard, the BEIR VII report states: ``in general the magnitude of
estimated risks for total cancer mortality or leukemia has not changed
greatly from estimates in past reports such as BEIR V and recent
reports of the United Nations Scientific Committee on the Effects of
Atomic Radiation (UNSCEAR) and the International Commission on
Radiological Protection (ICRP). New data and analyses have reduced
sampling uncertainty, but uncertainties related to estimating risk for
exposure at low doses and dose rates and transporting risks from
Japanese A-bomb survivors to the U.S. population remain large.
Uncertainties in estimating risks of site-specific cancers are
especially large.''
The NRC staff completed a review of the BEIR VII report and
documented its findings in the Commission paper SECY-05-0202, ``Staff
Review of the National Academies Study of the Health Risks from
Exposure to Low Levels of Ionizing Radiation (BEIR VII),'' dated
October 29, 2005 (ADAMS accession number ML052640532). In this paper,
the NRC staff concluded that the findings presented in the BEIR VII
report agree with the NRC's current understanding of the health risks
from exposure to ionizing radiation. The BEIR VII report's major
conclusion is that current scientific evidence is consistent with the
hypothesis that there is a linear, no-threshold dose response
relationship between exposure to ionizing radiation and the development
of cancer in humans. This conclusion is consistent with the system of
radiological protection that the NRC used to develop its regulations
and the GEIS. Therefore, the NRC's regulations and the GEIS continue to
be adequately protective of public health and safety and the
environment. Consequently, none of the findings in the BEIR VII
[[Page 71085]]
report represent new and significant information when compared to the
findings of the BEIR V report and thus, there is no need to amend NRC
regulations or the GEIS. The NRC has determined that a specific
rulemaking to amend 10 CFR Part 51 and by extension, the GEIS, is not
warranted.
Public Comments
The NRC received a total of 74 public comments relating to this
petition. Of the 74 comments, 69 supported granting the petition. No
comments opposed the petition and five comments were not applicable to
this petition. The letters in support of the petition were essentially
identical and contained one or more of the following four assertions:
A. Protect the most vulnerable populations in the regulatory
standards.
B. Recognize that ``allowable'' levels are not safe.
C. Consider radiation damage from inhaling or ingesting
radionuclides; and
D. Recognize that there is no safe dose.
A. Protect the Most Vulnerable Populations in the Regulatory Standards
Although some epidemiological studies have shown that children,
individuals in poor health, and the elderly are more radiosensitive to
radiation at high doses and high dose rates, no adverse health effects
have been observed in these populations at the doses associated with
NRC's radiation protection regulations and standards. The NRC, in NUREG
1850, ``Frequently Asked Questions on License Renewal of Nuclear Power
Reactors,'' provides information on a number of studies that have been
performed to examine the health effects around nuclear power
facilities. These studies report that there is no conclusive evidence
which shows a statistical correlation between the low level radiation
dose received by members of the public living near a nuclear power
plant and their cancer incidence.
The dose from radioactive gaseous and liquid effluents is based on
the ``maximum exposed individual'' and calculated to each of the four
age groups (0-1, 1-11, 11-17, and 17 years and older). The methodology
and guidance for calculating these doses and the associated dose
conversion factors for each age group, are contained in Regulatory
Guide 1.109, ``Calculation of Annual Doses to Man from Routine Releases
of Reactor Effluents for the Purpose of Evaluating Compliance with 10
CFR Part 50, Appendix I.'' Nuclear power reactors implement this
methodology and guidance in individual plant radiation protection
programs and operating procedures. The NRC has concluded that the
current NRC radiation protection standards continue to ensure adequate
protection of the public. This position is further reiterated in the
Commission Paper SECY-05-0202. In this paper, the NRC staff reviewed
and evaluated NRC's radiation safety regulations and standards against
the findings of the BEIR VII report. The NRC staff concluded ``that the
findings presented in the National Academies BEIR VII report contribute
to our understanding of the heath risks from exposure to ionizing
radiation. The major conclusion is that current scientific evidence is
consistent with the hypothesis that there is a linear, no-threshold
dose response relationship between exposure to ionizing radiation and
the development of cancer in humans.'' The BEIR VII report's conclusion
is consistent with the system of radiological protection that the NRC
used to develop its regulations and the GEIS. Therefore, the NRC
concludes that the current regulations continue to be adequately
protective of the public health and safety and the environment.
Consequently, none of the findings in the BEIR VII report warrant
initiating any immediate change to NRC regulations or the GEIS.
B. Recognize That ``Allowable'' Levels Are Not Safe
Commenter states that these levels are based on obsolete ``standard
man,'' concept that applies to a healthy, white male in the prime of
his life, and ignore the more vulnerable fetus, growing infant,
children, and women who, according to the BEIR VII report, are 37-50
percent more vulnerable than men to the harmful effects of ionizing
radiation. Although some epidemiological studies have shown that
children, individuals in poor health, and the elderly are more
radiosensitive to radiation at high doses and high dose rates, no
adverse health effects have been observed in these populations at the
doses associated with NRC's radiation protection regulations and
standards. The amount of radioactive material released from nuclear
power facilities is well measured, closely monitored, and known to be
very small. As shown by the studies referenced in NUREG-1850, the
radiation dose received by members of the public from the normal
operation of a nuclear power plant are so low that no cancers have been
observed.
The BEIR VII committee's preferred estimate of lifetime
attributable risk for solid cancer incidence and mortality (Tables 12-
13) suggest that females are more sensitive than males to radiation
exposure at 10 rem, a level that is 100 times the NRC's radiation
protection standards specified in 10 CFR Part 20. The BEIR VII
committee's preferred estimate of lifetime attributable risk for
leukemia cancer incidence and mortality (Tables 12-13), moreover,
suggest that males are more sensitive than females. The BEIR VII
committee uses the 95 percent confidence intervals associated with
estimated lifetime cancer risk for males and females that suggest that
the apparent gender difference may not be statistically significant.
Consequently, the BEIR VII report combined the two risk estimates and
cited an average value which was also done by the BEIR V committee. A
potential gender difference was not discussed in the BEIR VII report.
The NRC radiation protection regulation, 10 CFR 20.1208, requires
each licensee to ensure that the dose equivalent to the embryo/fetus
during the entire pregnancy, due to the occupational exposure of a
declared pregnant woman, does not exceed 0.5 rem (5 mSv). These
radiation protection standards continue to ensure adequate protection
of the public health and safety and the environment.
The petitioner has also requested that the NRC review an article
entitled ``Healthy from the Start: Building a Better Basis for
Environmental Health Standards--Starting with Radiation,'' published by
the Institute for Energy and Environmental Research (IEER), February
2007. This article was not published in a scientific peer-reviewed
journal and the article's conclusions do not appear to have been
subjected to an independent peer review process. The authors of this
article have stated that there are cause-and-effect relationships in
the statistical associations between cancer rates and nuclear power
reactor operations. Although it is true that cancer rates vary among
locations, it is difficult to ascribe the cause of a cluster of cancers
to a specific environmental agent, such as radiation from a nuclear
power plant. Statistical association alone does not demonstrate
causation. Also, well-established scientific methods must be used to
demonstrate that these causal effects are appeared to be associated
over time. Discussions regarding infants, children, and women are
addressed in section A of this document.
C. Consider Radiation Damage From Inhaling or Ingesting Radionuclides
The issue of radiation risks, as discussed in the GEIS (i.e.,
Appendix E, section E 4.1.1), used a reference value of 1 rem to
calculate the estimated
[[Page 71086]]
number of excess cancer fatalities, based on the BEIR V report. As
discussed in the section titled, ``BEIR Reports,'' while the changes
between the reports has increased our understanding of radiation risk,
none of the findings of the BEIR VII report represent new and
significant information when compared to the findings of the BEIR V
report. Thus, there is no need to amend NRC regulations or the GEIS.
Human health effects associated with ionizing radiation, which the
GEIS classifies as a Category 1 issue, are divided into two broad
categories, non-stochastic and stochastic. The non-stochastic health
effects are those in which the severity varies in direct relationship
with the radiation dose and for which, according to scientific reports
from ICRP, UNSCEAR, as well as the BEIR committee, a dose threshold is
known to exist. Radiation-induced cataract formation is an example of a
non-stochastic effect. The stochastic health effects are those that
occur randomly and for which the probability of the effect occurring,
rather than its severity, is assumed to be a linear function of dose
without threshold. Hereditary effects and cancer incidences are
examples of stochastic effects. For the mitigation of stochastic health
effects, the NRC endorses the linear, no-threshold dose response model
as a basis for its radiation protection standards. This model indicates
that any increase in radiation dose, no matter how small, results in an
incremental increase in the risk of adverse health effects.
NRC regulations and standards, such as the annual dose limits
contained in 10 CFR Part 20 for members of the public and for
occupational workers, account for stochastic and non-stochastic health
effects of radioactive material inhaled or ingested into the human
body. For members of the public, the annual dose limit from exposure to
radiation from an NRC licensed facility is 0.1 rem. For occupational
workers, there are specific dose limits to address the stochastic and
non-stochastic health effects. The total effective dose equivalent
limit which addresses the stochastic health effects is limited to an
annual dose of 5 rem. To address the non-stochastic health effects, the
annual dose limit to any individual organ or tissue and the skin, other
than the lens of the eye, is 50 rem; the annual dose limit to the lens
of the eye is 15 rem. The dose unit is specified as TEDE in rem. The
TEDE dose is the sum of the deep-dose equivalent (i.e., external
exposures) and the committed effective dose equivalent (i.e., internal
exposures received from inhaling or ingesting of radioactive material
which includes alpha, beta, gamma, and neutron emitters). The current
dose regulations and standards contain adequate radiation safety limits
based on radiation exposures from all types of radioactive material and
therefore, continue to ensure adequate protection of the public and
occupational workers.
Further, Appendix I to 10 CFR Part 50 provides numerical ALARA dose
criteria for the discharge of radioactive gaseous and liquid effluents
from nuclear power plants. These dose objectives are incorporated into
each nuclear power plant's license conditions. The NRC collects and
assesses data regarding licensees' adherence to regulations based on
site visits, audits and inspection records, and the annual radiological
effluent release reports required to be submitted to the NRC and
concludes that nuclear power plants continue to maintain their
radioactive effluents to the ALARA dose criteria.
D. Recognize That There Is No Safe Dose
The BEIR VII report's major conclusion is that current scientific
evidence is consistent with the hypothesis that there is a linear, no-
threshold dose response relationship between exposure to ionizing
radiation and the development of cancer in humans. The BEIR VII
committee did not attempt to equate radiation exposure and safety, nor
did it offer any judgment or opinion on what constitutes a safe level
of radiation exposure. It concludes that establishing limits on public
exposure to ionizing radiation is the responsibility of Federal
agencies like the U.S. Environmental Protection Agency and the NRC. The
linear, no-threshold dose response relationship between exposure to
ionizing radiation and the development of cancer in humans is
consistent with the system of radiological protection that the NRC uses
as a basis to develop its regulations. Therefore, the NRC's regulations
continue to ensure adequate protection of the public health and safety
and the environment.
Reasons for Denial
The Commission is denying the petition for rulemaking submitted by
Sally Shaw. The specific issues contained in the petition are already
adequately addressed in the NRC's radiation protection regulations and
standards.
Although this petition is being denied, the Commission notes that
the current GEIS that referenced the BEIR V, 1999 report, is undergoing
planned revision and will consider recent radiological studies,
including the BEIR VII, 2005 report. The summary of findings as a
result of the planned update will be codified through an ongoing and
routine rulemaking to 10 CFR Part 51, Subpart A, Appendix B, Table B1--
Summary of Findings on NEPA Issues for License Renewal of Nuclear Power
Plants.
The Commission has concluded that nuclear plants that are in
compliance with NRC radiation protection regulations and standards
remain protective of public health and safety and the environment. The
radiological health and environmental impacts contained in the GEIS,
which are based on regulatory compliance, remain valid.
For these reasons, the Commission denies PRM-51-11.
Dated at Rockville, Maryland, this 10th day of December 2007.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E7-24291 Filed 12-13-07; 8:45 am]
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